BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 19605013 · Received June 25, 2024

    Report

    Report Number
    1644487-2024-00764
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 25, 2024
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750054
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVAS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR MALFUNCTIONS. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SENSORY ISSUES DUE TO THE PRESENCE OF THE VNS. THEIR VNS IS TO BE REMOVED AS A RESULT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481883 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS - HOUSTON 105 203187 05425025750054

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other